Table 3

Immunogenicity in the phase III VOLTAIRE RCTs6–8

StatusVOLTAIRE-RAVOLTAIRE-CDVOLTAIRE-PsO
Adalimumab-adbm
(n=324)
Adalimumab RP
(n=321)
Adalimumab-adbm
(n=72)
Adalimumab RP (n=75)Adalimumab-adbm
(n=159)
Adalimumab RP
(n=158)
Antibody first detectable
ADABaselineBaselineBaselineWeek 4BaselineBaseline
nAbBaselineBaselineWeek 4Week 4BaselineBaseline
ADA titre at primary endpoint, median (Q1, Q3)16 (4, 64) at W12 32 (8, 128) at W2416 (4, 64) at W12 32 (8, 96) at W2416.0 (2.0, 32.0) at W42.5 (1.0, 34.0) at W432.0 (16, 128) at W1632.0 (16, 128) at W16
Proportion of patients with antibodies over time
ADA positive**
 Baseline3.4% (11/323)6.5% (21/321)4.3% (3/69)0% (0/74)10.7% (17/159)10.8% (17/158)
 Week 420.1% (64/319)19.9% (63/316)20.6% (14/68)5.5% (4/73)
 Week 1668.2% (101/148)71.8% (107/149)
 Week 2443.6% (129/296)47.8% (144/301)69.5% (41/59)45.9% (28/61)75.3% (113/150)77.9% (113/145)
 Week 4841.9% (119/284)42.6% (120/282)63.5% (33/52)51.8% (29/56)
nAb positive**
 Baseline2.8% (9/323)5.0% (16/321)0% (0/69)0% (0/74)0.6% (1/159)1.9% (3/158)
 Week 46.6% (21/319)7.6% (24/316)8.8% (6/68)2.7% (2/73)
 Week 1654.1% (80/148)55.7% (83/149)
 Week 2416.2% (48/296)20.9% (63/301)35.6% (21/59)23.0% (14/61)52.7% (79/150)57.2% (83/145)
 Week 4819.4% (55/284)17.7% (50/282)25.0% (13/52)19.6% (11/56)
  • *Reported in the randomised population at baseline.

  • ADA, antidrug antibody; CD, Crohn’s disease; nAb, neutralising antibody; PsO, chronic plaque psoriasis; Q, quarter; RA, rheumatoid arthritis; RCTs, randomised controlled trials; RP, reference product; W, week.